EndoTool IV (3.1)
FDA 510(k) K241088 · Monarch Medical Technologies
510(k) numberK241088
Submission
- Device name
- EndoTool IV (3.1)
- Applicant
- Monarch Medical Technologies
Charlotte, NC, US - Received
- April 19, 2024
- Decision date
- December 11, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NDC – Calculator, Drug Dose
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1890
- Specialty
- Anesthesiology
Other 510(k)s with product code NDC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254102 | GlucommanderNDC · Traditional | Glytec, LLC | 05/27/2026SE |
| K260910 | EndoTool IV Cloud 1.0NDC · Traditional | Glooko, Inc. | 05/01/2026SE |
| K253512 | MiniMed Go AppNDC · Traditional | Medtronic Minimed | 01/08/2026SE |
| K253281 | UpDocNDC · Traditional | Updoc, Inc. | 12/23/2025SE |
| K252104 | T1D1NDC · Traditional | Comerge AG | 08/20/2025SE |
| K242775 | InPen System App (MMT-8060 (iOS), MMT-8061 (Android))NDC · Traditional | Medtronic Minimed | 11/12/2024SE |
| K242066 | iSage RxNDC · Traditional | Amalgam Rx, Inc. | 08/21/2024SE |
| K232451 | Insulia Bolus CompanionNDC · Traditional | Voluntis Sa. | 12/12/2023SE |
| K230813 | BlueStar and BlueStar RxNDC · Traditional | Welldoc, Inc. | 07/28/2023SE |
| K221924 | Digital RoutinesNDC · Traditional | Gnc Holdings, LLC | 03/15/2023SE |
More from Gnc Holdings, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K211160 | EndoTool SubQ 2.1NDC · Traditional | 10/28/2021SE |
| K201619 | EndoTool IV SystemNDC · Traditional | 08/07/2020SE |
| K200443 | EndoTool IV 1.10NDC · Traditional | 03/17/2020SE |
| K142918 | EndoTool SubQNDC · Traditional | 04/24/2015SE |
| K132547 | Endo Tool Glucose Management System (Egms)NDC · Abbreviated | 04/17/2014SE |
Questions and answers
When was EndoTool IV (3.1) cleared by the FDA?
EndoTool IV (3.1) (K241088) received a 510(k) decision of Substantially Equivalent on December 11, 2024, 236 days after the submission was received.
What is the product code of K241088?
The FDA product code is NDC – Calculator, Drug Dose, a Class II (moderate risk) device regulated under 21 CFR 868.1890.